FDA Examines Health Complaints against Essure Contraceptive Implant
At the request of the FDA, an expert panel recently convened to discuss the rising number of complaints against the Essure contraceptive device. The Essure device consists of a small metal and polyester coil that gets implanted into the fallopian tubes to prevent future pregnancies.
The panel of experts sharply criticized Bayer Healthcare Pharmaceuticals, the manufacturer of Essure, for failing to collect the data necessary to accurately predict potential health risks associated with the contraceptive device. When Essure was approved by the FDA 13 years ago, it received a fast-track review process because it offered women the first alternative to surgical sterilization.
However, the FDA has received approximately 17,000 adverse event reports over the last 13 years from women who claim the Essure device resulted in a variety of injuries, including:
- Severe pain
- Perforations of fallopian tubes
- Autoimmune problems
- Severe fatigue
- Loss of bowel control
Bayer continues to defend Essure, claiming their preliminary studies adequately established it as a safe device. Nevertheless, the company currently faces numerous dangerous medical device lawsuits over Essure.
It's unclear whether the panel of expert testimony will prompt the FDA to issue a warning or even initiate a recall of Essure. However, it's important to know that you have rights if you've suffered an injury from using Essure.
Kimberly Wilson White has more than 15 years of experience handling defective medical device cases, and she has made this area of law a primary focus of her practice. This experience, combined with a Master's degree in Public Health, give Ms. White a unique background in this complex area of law. If you've suffered an injury from using the Essure device, Kimberly Wilson White will fight aggressively to hold the device manufacturer accountable for your damages.
Please contact Wilson Law, P.A. using the form at the bottom of the page or call (919) 800-0919 today to schedule a free Essure injury consultation. We serve clients in Raleigh, Durham, Chapel Hill, and throughout North Carolina.